BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMATILE

    MDR report key: 10797264 · Received November 5, 2020

    Report

    Report Number
    3014663932-2020-00002
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 3, 2020
    Manufacturer
    GT MEDICAL TECHNOLOGIES
    Product Code
    KXK
    UDI-DI
    60860000064509
    PMA / PMN Number
    K190839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO CASES HAVE BEEN REPORTED TO THE MANUFACTURER REGARDING ADVERSE EVENTS AFTER THE IMPLANTATION OF GAMMATILE. THESE INCIDENTS OCCURRED ON DIFFERENT DATES WITH DIFFERENT PATIENTS. THE LOTS OF GAMMATILES WERE SEPARATE LOTS USED BY THE SAME MEDICAL INSTITUTION. THE COLLAGEN CARRIER IN THE TWO BATCHES WAS FROM DIFFERENT LOTS. THE STERILIZATION WAS DONE ON TWO SEPARATE DATES. THE CS-131 RADIATIVE RADIOACTIVE SOURCE SEEDS WERE FROM TWO DIFFERENT LOTS. IT IS CURRENTLY UNKNOWN IF THE ADVERSE EVENTS ARE RELATED TO THE USE OF GAMMATILE. THE MEDICAL PHYSICIST DID REPORT THAT THERE WERE ABOUT 2 TIMES AS MANY CLINICIANS IN THE ROOM TO OBSERVE THE SURGERY. GT MEDICAL HAS ATTEMPTED FOLLOW-UP WITH THE USER VIA EMAIL AND PHONE BUT HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL FOLLOW-UP WILL BE ATTEMPTED AND THE MDR WILL BE UPDATED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    3 WEEKS POST-IMPLANTATION THE PATIENT HAD TO UNDERGO REMOVAL OF THE GAMMATILES DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257592 GAMMATILE RADIONUCLIDE BRACHYTHERAPY SEEDS KXK GT MEDICAL TECHNOLOGIES DO2036-009 60860000064509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention